Detailed alarm messages and support

This patent application is a continuation patent application of U.S. patent application Ser. No. 17/322,754, filed May 17, 2021, now U.S. Pat. No. 11,950,174 which claims benefit of U.S. Provisional Patent Application No. 63/120,712 filed Dec. 2, 2020, both of which are incorporated herein by reference in their entirety for all purposes.

When people suffer from some types of heart arrhythmias, in some instances, blood flow to various parts of the body may be reduced. Some arrhythmias can result in a Sudden Cardiac Arrest (SCA). SCA can lead to death quickly, e.g., within 10 minutes, unless treated in the interim. Some observers have thought that SCA is the same as a heart attack, which it is not.

Some people have an increased risk of SCA. Such people may include patients who have had a heart attack or a prior SCA episode. A frequent recommendation for these people is to receive an Implantable Cardioverter Defibrillator (ICD). The ICD is surgically implanted in the chest and continuously monitors the patient's intracardiac electrogram (IEGM). If certain types of heart arrhythmias are detected, then the ICD delivers an electric shock through the heart.

As a further precaution, people who have been identified to have an increased risk of SCA may wear a Wearable Cardioverter Defibrillator (WCD) system until an ICD is implanted. Early versions of such systems were called wearable cardiac defibrillator systems. A WCD system typically includes a harness, vest, belt, or other garments that the patient wears. The WCD system further includes electronic components, such as a defibrillator and electrodes, coupled to the harness, vest, or another garment. When the patient wears the WCD system, the electrodes may electrically contact the patient's skin and aid in sensing the patient's electrocardiogram (ECG). If a shockable heart arrhythmia (e.g., ventricular fibrillation or VF) is detected from the ECG, then the defibrillator delivers an appropriate electric shock through the patient's body through the heart. The delivered shock may restart the patient's heart and save the patient's life.

This summary is provided to introduce a selection of concepts in a simplified form that is further described below in the Detailed Description. This summary is not intended to identify key features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

The present disclosure describes instances and examples of cardiac monitoring systems (e.g., WCD systems), devices, systems, storage media that may store programs and methods.

In one embodiment, a method to alert a user of a status or condition wearable cardioverter defibrillator (WCD) is described. The method includes determining when a condition requires user alert and pushing the patient alert to a remote device in communication with the WCD and associated with the user based at least in part on the determining.

In some embodiments, the method may include pushing user health and location data to the remote device. The data may include at least one of an age, weight, cardiac history, location of the user, or some combination thereof. In some embodiments, the method may include determining when the condition requires intervention and pushing an alert to the remote device based on the required intervention. In some embodiments, the method may include detecting a cardiac event requiring medical intervention and pushing an emergency alert to the remote device to activate an emergency protocol.

In one embodiment, a method of alerting a user of a WCD is described. The method includes receiving an alert from the WCD on a remote device associated with the user and in communication with the WCD and transcribing the alert into a message for the user. The method also includes personalizing the message for the user and delivering the message to the user via the remote device.

In some embodiments, delivering the message to the user may include delivering a unique message alert with a personalized message presentation. In some embodiments, the personalized message may include a name of the user. In some embodiments, the message may include one or more of an audio message, a voice message, and a video message.

In some embodiments, delivering the message to the user may include delivering a unique message alert with a personalized message presentation based at least in part on preferences selected by the user. Delivering the message to the user may include delivering a unique message alert with a personalized message presentation based at least in part on learned preferences based on user interactions.

In some embodiments, the method may include receiving an alert to troubleshoot a problem with the WCD and prompting the user to use the remote device to troubleshoot the problem with the WCD. The method may request permission to access a camera on the remote device and use the camera to troubleshoot the problem with the WCD when permission is granted.

In some embodiments, the method may include receiving an emergency alert from the WCD and activating an emergency alert protocol. The method may further include determining a location of the user and transmitting the location of the user to emergency personnel. The method may also include transmitting user data to the emergency personnel. In some embodiments, the method may contact an emergency contact per the emergency alert protocol. The method may also contact an attending physician of the user and deliver the emergency alert to the attending physician.

In some embodiments, the method may include tracking user interaction with the remote device and learning preferred user interaction based at least in part on the tracking. The method may also personalize alerts and notifications to the user based on the preferred user interaction. In some embodiments, the method may store the alert from the WCD in a memory of the remote device.

In one embodiment, a method of alerting a user of a WCD is described. The method includes receiving an alert from the WCD on a remote device associated with the user and transcribing the alert into a message on the remote device. The method also includes personalizing the message from the WCD into a unique message with a name of the user and delivering the unique message to the user via the remote device. Finally, the method stores the alert from the WCD in a memory of the remote device.

The detailed description set forth below in connection with the appended drawings, where like numerals reference like elements, are intended as a description of various embodiments of the present disclosure and are not intended to represent the only embodiments. Each embodiment described in this disclosure is provided merely as an example or illustration and should not be construed as precluding other embodiments. The illustrative examples provided herein are not intended to be exhaustive or limit the disclosure to the precise forms disclosed.

In the following description, specific details are set forth to provide a thorough understanding of exemplary embodiments of the present disclosure. However, it will be apparent to one skilled in the art that the embodiments disclosed herein may be practiced without embodying all of the specific details. In some instances, well-known process steps have not been described in detail in order not to unnecessarily obscure various aspects of the present disclosure. Further, it will be appreciated that embodiments of the present disclosure may employ any combination of features described herein.

Wearable Cardioverter Defibrillators (WCDs) are worn by patients at risk for sudden cardiac arrest. The WCD system uses alarms to keep users informed of equipment and physiological conditions that may require the user's attention. However, the WCD itself may have precursory information. For example, the WCD system may communicate basic alarm content in which detailed alert information may be perfunctory or difficult to ascertain. The alert content may be available on the large defibrillator module, which does not allow the patient to interact with the device discretely. The alert content also uses memory, battery, and other resources of the defibrillator module.

By linking the WCD system to at least one remote device, the alert and alarm messages may become more meaningful and impactful to a patient and the patient's team. The term remote device and mobile device may be used interchangeably throughout the application. The patient may discretely receive and view information from the WCD device. However, all of the information is still maintained and controlled by the WCD. The WCD remains fully operational and effective without the mobile device application, thereby not compromising the patient's safety or health. The mobile application and remote device merely aid in the patient's comfort of interfacing with the WCD system.

In some embodiments, the mobile device may enhance the patient's interactions with the WCD unit. For example, the mobile device may present content in multiple formats, including videos, interactive animations, three-dimensional visualizations, among other methods. In some embodiments, the remote device may uniquely customize the alerts through the application. For example, the remote device may include a personalization such as the patient's name in its alerts. In some embodiments, the remote device may detect and utilize a patient's location when issuing alarms. For example, the remote device may detect when devices are present, which may interfere with the operation of the WCD.

In further embodiments, the patient may customize the messages. For example, some patients may prefer text messages or text alerts. Others may wish to receive a voice memo or a phone call to convey information. In some embodiments, patients may wish to receive one or more videos. The videos may contain an alert or information on troubleshooting a potential problem. If the remote device includes a camera, the remote device may use augmented reality to help a patient troubleshoot a potential issue with the WCD system.

In some embodiments, the remote device may also tailor the messages and alerts to increase patient response time. For example, the system may learn the preferred presentation of alarm message content and further customize future message appearances and delivery of the content. The system may track patient responses to specific messages to determine which messages are delivered and addressed efficiently and effectively. The delivery may include the type of messages, such as voice, text, or video, but may also include the alert mode programmed into the phone, the time of day, environmental concerns, and the like. The system may begin to tailor the message delivery to increase the responsivity of a patient.

illustrates a systemwith a patientwearing an example of a WCD systemaccording to embodiments described herein. In some embodiments, the WCD systemmay include one or more communication devices, a support structure, and an external defibrillatorconnected to two or more defibrillation electrodes,, among other components.

The support structuremay be worn by the patient. The patientmay be ambulatory, meaning the patientcan walk around and is not necessarily bed-ridden while wearing the wearable portion of the WCD system. While the patientmay be considered a “user” of the WCD system, this is not a requirement. For instance, a user of the WCD systemmay also be a clinician such as a doctor, nurse, emergency medical technician (EMT), or other similarly tasked individual or group of individuals. In some cases, a user may even be a bystander. The particular context of these and other related terms within this description should be interpreted accordingly.

In some embodiments, the support structuremay include a vest, shirt, series of straps, or other system enabling the patientto carry at least a portion of the WCD systemon the patient's body. In some embodiments, the support structuremay comprise a single component. For example, the support structuremay comprise a vest or shirt that properly locates the WCD systemon a torso of the patient. The single component of the support structuremay additionally carry or couple to all of the various components of the WCD system.

In other embodiments, the support structuremay comprise multiple components. For example, the support structuremay include a first component resting on a patient's shoulders. The first component may properly locate a series of defibrillation electrodes,on the torso of the patient. A second component may rest more towards a patient's hips, whereby the second component may be positioned such that the patient's hips support the heavier components of the WCD system. In some embodiments, the heavier components of the WCD systemmay be carried via a shoulder strap or may be kept close to the patient, such as in a cart, bag, stroller, wheelchair, or other vehicles.

The external defibrillatormay be coupled to the support structureor carried remotely from the patient. The external defibrillatormay be triggered to deliver an electric shock to the patientwhen patientwears the WCD system. For example, if certain thresholds are exceeded or met, the external defibrillatormay engage and deliver a shock to the patient.

The defibrillation electrodes,can be configured to be worn by patientin several ways. For instance, the defibrillatorand the defibrillation electrodes,can be coupled to the support structuredirectly or indirectly. For example, the support structurecan be configured to be worn by the patientto maintain at least one of the electrodes,on the body of the patient, while the patientis moving around, etc. The electrodes,can be thus maintained on the torso by being attached to the skin of patient, simply pressed against the skin directly or through garments, etc. In some embodiments, the electrodes,are not necessarily pressed against the skin but become biased that way upon sensing a condition that could merit intervention by the WCD system. In addition, many of the components of defibrillatorcan be considered coupled to support structuredirectly or indirectly via at least one of the defibrillation electrodes,.

The WCD systemmay defibrillate the patientby delivering an electrical charge, pulse, or shockto the patientthrough a series of electrodes,positioned on the torso. For example, when defibrillation electrodes,are in good electrical contact with the torso of patient, the defibrillatorcan administer, via electrodes,, a brief, strong electric pulsethrough the body. The electric pulseis also known as shock, defibrillation shock, therapy, electrotherapy, therapy shock, etc. The electric pulseis intended to go through and restart heartin an effort to save the life of patient. The electric pulsecan further include one or more pacing pulses of lesser magnitude to pace heartif needed. The electrodes,may be electrically coupled to the external defibrillatorvia a series of electrode leads. The defibrillatormay administer an electric shockto the body of the patientwhen the defibrillation electrodes,are in good electrical contact with the torsoof patient. In some embodiments, devices (not shown) proximate the electrodes,may emit a conductive fluid to encourage electrical contact between the patientand the electrodes,.

In some embodiments, the WCD systemmay also include either an external or internal monitoring device or some combination thereof.displays an external monitoring device, which may also be known as an outside monitoring device. The monitoring devicemay monitor at least one local parameter. Local parameters may include a physical state of the patient, such as ECG, movement, heart rate, pulse, temperature, and the like. Local parameters may also include a parameter of the WCD, environmental parameters, or the like. For example, in some embodiments, the monitoring devicemay include sensors to gather patient movement, ambient lighting, and the like. The monitoring devicemay be physically coupled to the support structureor may be proximate to the support structure. In either location, the monitoring deviceis communicatively coupled with other components of the WCD.

For some of these parameters, the devicemay include one or more sensors or transducers. Each one of such sensors can be configured to sense a parameter of the patientand to render an input responsive to the sensed parameter. In some embodiments, the input is quantitative, such as values of a sensed parameter; in other embodiments, the input is qualitative, such as informing whether or not a threshold is crossed. In some instances, these inputs about the patientare also referred to herein as patient physiological inputs and patient inputs. In some embodiments, a sensor can be construed more broadly as encompassing many individual sensors.

In some embodiments, a communication devicemay enable the patientto interact with and garnish data from the WCD system. The communication devicemay enable a patient or third party to view patient data, dismiss a shock if the patient is still conscious, turn off an alarm, and otherwise engage with the WCD system. In some instances, the communication devicemay transfer or transmit information, including patient data, to an external device, a third-party data server such as a cloud server or a blockchain server. In some embodiments, the communication devicemay be a separable part of an external defibrillator. For example, the communication devicemay be a separate device coupled to the external defibrillator. In some embodiments, the communication devicemay be wired or wirelessly linked to the external defibrillatorand may be removable from the defibrillator. In other embodiments, the communication devicemay form an inseparable assembly and share internal components with the external defibrillator. In some embodiments, the WCD systemmay include more than one communication device. For example, the defibrillatormay include components able to communicate to the patient, and the WCD systemmay include a separate communication deviceremote from the defibrillator.

In some embodiments, the communication devicemay be communicatively coupled to an button. The buttonmay be removably coupled to the support structure. The patientmay couple the buttonto the support structureor couple the buttonto an article of clothing. The buttonmay have a wired connection or be wirelessly connected to the communication device. In some embodiments, the buttonmay include a visual output, an audio output, and a user input. The visual output may include a light, such as an LED, a small screen, or some combination thereof. Likewise, the audio output may include one or more speakers. The output of the audio output may be loud enough to be heard over nominal background noise. In some embodiments, the audio output might have an adjustable volume range. In some embodiments, the buttonmay include a microphone. In still further embodiments, the buttonmay also include a haptic response.

In some embodiments, the defibrillatormay connect with one or more external devices. For example, as shown in, the defibrillatormay connect to one or more various external devicessuch as the cloud, a remote desktop, a laptop, a mobile device, a watch, a tablet, a phablet, or other external device using a network such as the Internet, local area networks, wide area networks, virtual private networks (VPN), other communication networks or channels, or any combination thereof.

In embodiments, one or more of the components of the exemplary WCD systemmay be customized for the patient. Customization may include several aspects including, but not limited to, fitting the support structureto the torsoof patient; baseline physiological parameters of patientcan be measured, such as the heart rate of patientwhile resting, while walking, motion detector outputs while walking, etc. The measured values of such baseline physiological parameters can be used to customize the WCD system to make its analysis more accurate since patients' bodies differ from one another. Such parameter values can be stored in a memory of the WCD system and the like. Moreover, a programming interface can be made according to embodiments, which receives such measured values of baseline physiological parameters. Such a programming interface may input automatically in the WCD system these, along with other data.

is a diagram displaying various components of an example external defibrillator. The external defibrillatormay be an example of the defibrillatordescribed with reference to. The components shown inmay be contained within a single unit or may be separated amongst two or more units in communication with each other. The defibrillatormay include a communication device, processor, memory, defibrillation port, and ECG port, among other components. In some embodiments, the components are contained within a housingor casing. The housingmay comprise a hard shell around the components or may comprise a softer shell for increased patient comfort.

The communication device, processor, memory(including software/firmware code (SW)), defibrillation port, ECG port, communication module, measurement circuit, monitoring device, and energy storage modulemay communicate, directly or indirectly, with one another via one or more buses. The one or more busesmay allow data communication between the elements and/or modules of the defibrillator.

The memorymay include random access memory (RAM), read-only memory (ROM), flash RAM, external memory drives, and/or other types. The memorymay store computer-readable, computer-executable software/firmware code, including instructions that, when executed, cause the processorto perform various functions (e.g., determine shock criteria, determine heart rate, issue shock command, issue alerts, etc.). In some embodiments, the processormay include an intelligent hardware device, e.g., a central processing unit (CPU), a microcontroller, an application-specific integrated circuit (ASIC), etc.

In some embodiments, the memorycan contain, among other things, the Basic Input-Output system (BIOS), which may control basic hardware and/or software operations such as interactions and workings of the various components of the defibrillator, and in some embodiments, components external to the defibrillator. For example, the memorymay contain various modules to implement the workings of the defibrillatorand other aspects of the present disclosure.

In some embodiments, the defibrillatormay include a user interface. The user interfacemay be in addition to or part of the communication device. The user interfacemay display an ECG of the patient, a status of the defibrillator, a status of a charge (e.g., a battery charge or an energy storage module), and the like.

In some embodiments, the defibrillatormay include a defibrillation port. The defibrillation portmay comprise a socket, opening, or electrical connection in the housing. In some instances, the defibrillation portmay include two or more nodes,. The two or more nodes,may accept two or more defibrillation electrodes (e.g., defibrillation electrodes,,). The nodes,may provide an electrical connection between the defibrillation electrodes,and the defibrillator. The defibrillation electrodes,may plug into the two or more nodes,via one or more leads (e.g., leads), or, in some instances, the defibrillation electrodes,may be hardwired to the nodes,. Once an electrical connection is established between the defibrillation portand the electrodes,, the defibrillatormay be able to deliver an electric shock to the patient.

In some embodiments, the defibrillatormay include an ECG portin the housing. The ECG portmay accept one or more ECG electrodesor ECG leads. In some instances, the ECG electrodessense a patient's ECG signal. For example, the ECG electrodesmay record electrical activity generated by heart muscle depolarization, timing, or both. The ECG electrodesmay utilize 4-leads to 12-leads or multichannel ECG, or the like. The ECG electrodesmay connect with the patient's skin.

In some embodiments, the defibrillatormay include a measurement circuit. The measurement circuitmay be in communication with the ECG port. For example, the measurement circuitmay receive physiological signals from ECG port. The measurement circuitmay additionally or alternatively receive physiological signals via the defibrillation portwhen defibrillation electrodes,are attached to the patient. The measurement circuitmay determine a patient's ECG signal from a difference in voltage between the defibrillation electrodes,.

In some embodiments, the measurement circuitmay monitor the electrical connection between the defibrillation electrodes,and the skin of the patient. For example, the measurement circuitcan detect impedance between electrodes,. The impedance may indicate the effective resistance of an electric circuit. An impedance calculation may determine when the electrodes,have a good electrical connection with the patient's body.

In some embodiments, the defibrillatormay include an internal monitoring devicewithin the housing. The monitoring devicemay monitor at least one local parameter. Local parameters may include a physical state of the patient such as ECG, movement, heart rate, pulse, temperature, and the like. Local parameters may also include a parameter of the WCD system (e.g., WCD,), defibrillator, environmental parameters, or the like.

In some embodiments, the WCD systemmay include an internal monitoring deviceand an external monitoring device (e.g., external monitoring device). If both monitoring devices,are present, the monitoring devices,may work together to parse out specific parameters depending on position, location, and other factors. For example, the external monitoring devicemay monitor environmental parameters while the internal monitoring devicemay monitor patient and system parameters.

In some embodiments, the defibrillatormay include a power source. The power sourcemay comprise a battery or battery pack, which may be rechargeable. In some instances, the power sourcemay comprise a series of different batteries to ensure the defibrillatorhas power. For example, the power sourcemay include a series of rechargeable batteries as a prime power source and a series of non-rechargeable batteries as a secondary source. If the patientis proximate to an AC power source, such as when sitting down, sleeping, or the like, the power sourcemay include an AC override wherein the power sourcedraws power from the AC source.

In some embodiments, the defibrillatormay include an energy storage module. The energy storage modulemay store electrical energy to prepare or anticipate providing a sudden discharge of electrical energy to the patient. In some embodiments, the energy storage modulemay have its own power source and/or battery pack. In other embodiments, the energy storage modulemay pull power from the power source. In still further embodiments, the energy storage modulemay include one or more capacitors. The one or more capacitorsmay store an electrical charge, which may be administered to the patient. The processormay be communicatively coupled to the energy storage moduleto trigger the amount and timing of electrical energy to provide to the defibrillation portand, subsequently, the patient.

In some embodiments, the defibrillatormay include a discharge circuit. The discharge circuitmay control the energy stored in the energy storage module. For example, the discharge circuitmay either electrically couple or decouple the energy storage moduleto the defibrillation port. The discharge circuitmay be communicatively coupled to the processorto control when the energy storage moduleand the defibrillation portshould or should not be coupled to either administer or prevent a charge from emitting from the defibrillator. In some embodiments, the discharge circuitmay include one or more switches. In further embodiments, the one or more switchesmay include an H-bridge.

In some embodiments, the defibrillatormay include a communication module. The communication modulemay establish one or more communication links with either local hardware and/or software to the WCD systemand defibrillatoror to remote hardwire separate from the WCD system. In some embodiments, the communication modulemay include one or more antennas, processors, and the like. The communication modulemay communicate wirelessly via radio frequency, electromagnetics, local area networks (LAN), wide area networks (WAN), virtual private networks (VPN), RFID, Bluetooth, cellular networks, and the like. The communication modulemay facilitate communication of data and commands such as patient data, episode information, therapy attempted, CPR performance, system data, environmental data, etc. In some embodiments, the communication modulemay include a display screen to display messages to the patient. In some embodiments, the display screen may be a touch screen, backlit screen, passive, reflective LCD screen, or the like.